FDA.reportPublic FDA data

Application 216244

Type
ANDA
Sponsor
EUGIA PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESMOLOL HYDROCHLORIDEESMOLOL HYDROCHLORIDEINJECTABLE;INJECTION10MG/MLNoNo
002ESMOLOL HYDROCHLORIDEESMOLOL HYDROCHLORIDEINJECTABLE;INJECTION20MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55150-420esmolol hydrochlorideesmolol hydrochloride in sodium chlorideAuroMedics Pharma LLCANDACurrent
55150-421esmolol hydrochlorideesmolol hydrochloride in sodium chlorideAuroMedics Pharma LLCANDACurrent